APPLICATION
ANDA091673
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-22
LATEST ACTION
2025-07-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 200MG BASE · CAPSULE · ORAL
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 100MG BASE · CAPSULE · ORAL
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 300MG BASE · CAPSULE · ORAL
ATAZANAVIR SULFATEPrescription
ATAZANAVIR SULFATE EQ 150MG BASE · CAPSULE · ORAL
Approval history
2025-07-23Labeling · Supplement 14 · standardAP
2024-10-18Labeling · Supplement 8 · standardAP
2024-10-18Labeling · Supplement 6 · standardAP
2024-10-18Labeling · Supplement 13 · standardAP
2024-10-18Labeling · Supplement 4 · standardAP
2024-10-18Labeling · Supplement 2 · standardAP
2024-10-18Labeling · Supplement 7 · standardAP
2024-10-18Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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